Home NDC 52261-0601 Berberex Wound Gel
Product NDC 52261-0601
11-digit product format 522610601
Labeler code 52261
Product ID 52261-0601_67cabb40-44f2-4ad0-ad14-77f4ab2bd1dc
Type HUMAN OTC DRUG
Nonproprietary name Benzethonium Chloride, Allantoin
Dosage form GEL
Route TOPICAL
Labeler Cosco International, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-01
Substance BENZETHONIUM CHLORIDE; ALLANTOIN
Active strength .0012; .005 kg/kg; kg/kg
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52261-0601-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52261-0601-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52261-0601-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52261-0601-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52261-0601-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52261-0601-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52261-0601-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Berberex Wound Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZETHONIUM CHLORIDE .0012 kg/kg ALLANTOIN .005 kg/kg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PH41D05744 Internal UNII lookup 344S277G0Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52261-0601-1 Berberex Wound Gel 0.0850 kg in 1 TUBE GEL 0.0850 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52261-0601 BERBEREX WOUND GEL (BENZETHONIUM CHLORIDE, ALLANTOIN) GEL [COSCO INTERNATIONAL, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250331_5dd97e65-bfb3-468e-a2b1-e56d30da99df.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 83 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XTRA Squeeze Antibacterial Hand Juicy Orange BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 2f03b094-c470-d0f4-e063-6394a90a47fc 2025-03-19 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 30997964-e81e-2159-e063-6294a90ad5dc 2025-03-18 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 309abafa-0118-dd48-e063-6294a90a6e9f 2025-03-18 Warnings Exact identifier application number: M003 Smart Care Strawberry Hand Sanitizer strawberry 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3086faf2-e6e3-a7da-e063-6394a90ace54 2025-03-17 Warnings Exact identifier application number: M003 AEROCLEANSE Instant Hand Sanitizer INSTANT HAND SANITIZER Aero Healthcare 45aad3a4-dc7e-4b51-e054-00144ff88e88 2025-03-12 Warnings Exact identifier application number: M003 Signature Care Instant Hand Sanitizizer Wipes ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. 0f6a30de-4100-4673-ab9e-256bb137919b 2025-03-11 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2fa8bf7a-8efc-923d-e063-6394a90a6bbb 2025-03-06 Warnings Exact identifier application number: M003 Jianerkang One Fluid Ounce Hydrogen Peroxide HYDROGEN PEROXIDE Jianerkang Medical Co., Ltd 0cd2cefc-89db-49f9-b187-150c21e7f671 2025-03-06 Warnings Exact identifier application number: M003 XTRA BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 27df3fce-3958-d4ea-e063-6394a90a1785 2025-03-06 Warnings Exact identifier application number: M003 XTRA BENZALKONIUM CHLORIDE MY IMPORTS USA LLC 27f4ff15-5480-8842-e063-6294a90ad35b 2025-03-06 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL Universal Distribution Center LLC 2f982aef-4f46-aa85-e063-6394a90a52b1 2025-03-05 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL Universal Distribution Center LLC 2f9846ce-37ca-a95b-e063-6294a90ad260 2025-03-05 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Universal Distribution Center LLC 2f988951-39e7-ec02-e063-6294a90aaad7 2025-03-05 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL Universal Distribution Center LLC 2f98a900-6c7c-0161-e063-6294a90ac675 2025-03-05 Warnings Exact identifier application number: M003 3 Hydrogen Peroxide HYDROGEN PEROXIDE Universal Distribution Center LLC 2f98ba8c-0ab1-e256-e063-6394a90abe8f 2025-03-05 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer Cherry Blossom 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2f800ea4-b8bb-0cb4-e063-6294a90a7e23 2025-03-04 Warnings Exact identifier application number: M003 Thera Plus Pain Relief Cleansing BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Fourstar Group USA, Inc. 513a620e-f69a-488d-8abc-36e2efccdc13 2025-03-04 Warnings Exact identifier application number: M003 Clorox Hand Sanitizer ALCOHOL Brand Buzz LLC bdd47d2f-5332-1430-e053-2a95a90a1c33 2025-03-03 Warnings Exact identifier application number: M003 T/T WAG Hand Sanitizer Mist Watermelon 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2f7c4066-3baa-25f2-e063-6394a90a00eb 2025-03-03 Warnings Exact identifier application number: M003 Procure Products Hand Sanitizing Wipes ALCOHOL 70% ANTIBACTERIAL WIPES TWIN MED LLC 1f378bee-88f7-14cf-e063-6394a90a4888 2025-02-28 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52261-0601-1 52261060101 .085 kg in 1 TUBE (52261-0601-1) 2022-07-01 0000-00-00 No No Current